Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102772
• Other study ID #: TJMUCH-GI-GC05
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: October 10, 2026

Study information

• Verified date: October 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Ting Deng, MD
• Phone: 022-23340123
• Email: xymcdengting[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.

Description:

The benefits of immunotherapy in first-line treatment for gastric cancer patients whose tumor tissue CPS<5 are limited. And some patients have not been treated by immunotherapy in the first-line treatment in clinical practice. This study intends to enroll first-line patients with advanced gastric cancer who have not been treated with PD-1 antibody, and explore the effectiveness and safety of second-line PD-L1 antibody combined with Fruquintinib and paclitaxel/albumin-paclitaxel, providing clues for the application of PD-L1 antibody in advanced gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 10, 2026
• Est. primary completion date: October 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old.

2. The ECOG score is 0-1 and does not deteriorate within 7 days.

3. Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.

4. Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.

5. There was no PD-1/PD-L1 inhibitor exposure in the first line.

6. Measurable lesions that meet RECIST 1.1 criteria.

7. Have adequate organ and bone marrow function, laboratory tests meet the following requirements:

1. HGB=90g/L;

2. NEUT=1.5×10^9/L;

3. PLT =80×10^9/L;

4. TBIL=1.5 times upper limit of normal value (ULN);

5. ALT and AST=2.5 x ULN; In liver metastasis, ALT and AST=5×ULN;

6. Endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula);

7. Urinary protein < (++), or 24-hour urinary protein volume < 1.0 g.

8. Normal coagulation function, no active bleeding

1. International standardized ratio INR=1.5;

2. Partial thromboplastin time APTT=1.5 ULN.

9. Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.

10. Expected survival =3 months.

11. Patients voluntarily joined the study and signed an informed consent form (ICF).

12. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.

Exclusion Criteria:

1. Previous treatment with VEGFR inhibitors;

2. Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the disease progression);

3. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;

4. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;

5. Previously received allogeneic bone marrow transplantation or organ transplantation;

6. Hypertension that could not be controlled by drugs before enrollment was defined as:

systolic blood pressure =150 mmHg and/or diastolic blood pressure =90 mmHg;

7. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;

8. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;

9. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months > 30 mL, hematemesis, stool, stool blood), hemoptysis, or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;

10. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure > Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) < 50%;

11. Active or uncontrolled severe infection (=CTCAE v5.0 grade 2 infection);

12. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or > 2000 IU/ mL); known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL);

13. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;

14. The patients considered by the investigators to be unsuitable for inclusion in this study.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Adebrelimab,Fruquintinib
Adebrelimab,Fruquintinib combined with chemotherapy

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Hughes PE, Caenepeel S, Wu LC. Targeted Therapy and Checkpoint Immunotherapy Combinations for the Treatment of Cancer. Trends Immunol. 2016 Jul;37(7):462-476. doi: 10.1016/j.it.2016.04.010. Epub 2016 May 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Time from the start of treatment to the progression of the disease	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary	Disease Control rate	The proportion of CR,PR and SD	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	The Overall Response Rate	The proportion of CR and PR	Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Overall survival	Time from the start of treatment to the occurrence of death	From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months